Clinical Trials for Back Pain, Leg Pain, Nerve Injury Pain

By Ted Swing, Ph.D.

We view clinical research as a critical tool in advancing the practice of pain medicine. Through these studies, we work with outside sponsors to test the latest treatments for pain in order to demonstrate their safety and efficacy. New types of treatments usually require supporting evidence from multiple studies before they can gain FDA approval for widespread use.

Seikagaku Herniated Disc Study

Low back pain is by far the most common form of chronic pain. For many patients, they experience pain in the low back that shoots down into one or both legs, sometimes accompanied by numbness. This can be caused by a herniation or bulging of one of one of the discs that separate the vertebral bones of the spine. When a disc bulges outward, it can put increased pressure on the nerve roots that run through the spine in the lower back and cause pain that travels along that nerve. In approximately 90% of cases, this type of pain (called radicular pain or lumbar radiculitis) can be relieved over time with conservative care, such as chiropractic care or physical therapy, medications or epidural steroid injections. If the pain remains at a high level, even after trying these treatments, patients may undergo surgery that removes part of the disc to relieve pressure on the nerve root.

For decades, researchers have been looking for less invasive alternatives to surgery. One promising alternative is a new drug that can be injected into the disc and cause the herniation to shrink inwards, permanently relieving pressure on the nerve root. Several studies in the U.S., Japan and Sweden have shown this treatment to be safe, with promising results for relieving pain. We are now testing this treatment in a phase III study (the last one required before potential FDA approval). Patients who have had moderate to severe low back pain that radiates into one or both legs for less than one year may be eligible for this study. In order to be eligible, patients must have not gotten adequate relief from several forms of conservative care but not yet had any surgery on their lumbar spine. Of those who are eligible and enroll, 75% receive the study drug and 25% receive a control injection.

St. Jude SENSE Study

Some patients with low back and leg pain continue to experience pain even after surgical interventions. These patients may be candidates for a type of implanted device called a spinal cord stimulator (SCS). SCS devices are implanted along the spine and deliver electrical stimulation to the spinal nerves that replaces pain with non-painful tingling sensation. These devices have been used successfully for years in treating pain both to the back and other areas, such as the legs. Though most patients get substantial pain relief from SCS devices, pain in certain areas has proven more difficult to cover for some patients.

St. Jude has developed a new type of SCS device that can also include one or more leads that extend out into the lower back to provide peripheral field stimulation. We are currently testing this device compared to the current device to see if it proves more effective for patients who have had back surgery and continue to experience moderate to severe low back and leg pain. Patients who enroll in this study will be randomly assigned to receive one of two types of devices — either the current SCS or the SCS/peripheral nerve field stimulation device.

Pfizer Lyrica Study

Injuries to the body, such as motor vehicle accidents, falls, crushing or burns, as well as surgical procedures, typically cause pain. In most cases, as the body heals the pain goes away. For some individuals, the injury also affects the nerves themselves, resulting in chronic pain that remains even after the person has otherwise healed. This pain is often distinguished by the area affected, which typically follows the path of a particular nerve branch. For example, a knee injury might cause lasting pain along the saphenous nerve which covers part of the leg.

Certain medications have been found to relieve such nerve pain. For example, pregabalin (Lyrica®) has proven effective for treating forms of nerve pain such as diabetic neuropathy. To date, it has not been studied specifically for the type of post-traumatic nerve pain described here. We are recruiting patients for a study of this type of nerve pain. Those who have chronic peripheral nerve pain (not affecting the spine or head) due to an injury or surgery may be eligible to enroll. Patients will be randomly assigned to receive either pregabalin or placebo for several months as their pain is assessed.
If you are interested in learning more about any of these studies, you can speak with your pain management providers or contact me directly at Teds@arizonapain.com.

Ted Swing has more than nine years of research experience and four years of teaching experience in psychology, has published in top psychology and medical journals, and has presented his research at major conferences. He received his Ph.D. in Social Psychology from Iowa State University and has been the Research Director at Arizona Pain since May 2012.

What’s going on in the Research department.

By Ted Swing, Ph.D.

The development of new treatments for pain depends on studies called clinical trials. Clinical trials are studies that typically take place at many locations around the country — sometimes around the world. The study is supported by a sponsor, but the treatments are overseen by doctors at each individual location. Clinical trials may study the effectiveness and safety of a new drug, a surgical procedure, or a medical device. At Arizona Pain, we are committed to advancing the treatment of pain, so we are taking part in several clinical trials.

Active Clinical Trials

St. Jude SENSE Study

Patients who have moderate to severe chronic pain that is not resolved by conservative treatments, such as rest, physical therapy, chiropractic care or medication therapy, may qualify for treatment with a device called a spinal cord stimulator. This is an implanted device that delivers electrical pulses to the nerves of the spine that disrupt pain signals, producing pain relief.St. Jude is conducting a study comparing the standard spinal cord stimulator to new type of device that stimulates both the spinal nerves as well as peripheral nerves in the lower back. The study is intended to test if patients who have had back surgery and continue to experience pain in the lower back and legs may get better relief from the combination system than the standard spinal cord stimulator.

Seikagaku Herniated Disc Study

The discs separating the spinal vertebrae can bulge outward, putting pressure on the nerve roots. When this happens in the lower back, it can cause pain and numbness that shoots down one or both legs.Seikagaku is studying a drug that is injected into the bulging disc that may be able to permanently shrink the bulging disc, relieving the pressure on the nerve root and the pain it causes. Patients who have suffered from back and leg pain due to a bulging disc for no more than one year and who have never had surgery in their lumbar spine may be eligible to participate. Of patients enrolled in this study, 75% receive an injection of this study drug and 25% receive a control treatment.

Pfizer Lyrica Post-Traumatic

Peripheral Nerve Pain Study

Traumatic injuries, such as car accidents, falls or even surgical procedures, sometimes leave patients with chronic nerve pain in the area of the injury. This can affect peripheral nerves, which are nerves outside of the head, neck or spine. Because this pain is due to damage or irritation of the nerve itself, it may last after the injury itself has healed. For example, a person may have injured their shoulder in a car accident and suffer chronic nerve pain that runs from their shoulder and into their arm.Lyrica is medication currently approved for several types of nerve pain. Pfizer is currently studying Lyrica for the potential to treat post-traumatic peripheral nerve pain as well. Patients who suffer from post-traumatic peripheral nerve pain may be eligible to enroll in the study and receive either Lyrica or a placebo medication for up to 17 weeks.

Pfizer Arthritis Cardiovascular

Disease Study

Osteoarthritis and rheumatoid arthritis are among the most common causes of chronic pain. Many patients with these conditions require treatment with anti-inflammatory medications, such as ibuprofen (e.g., Advil®), naproxen (e.g., Aleve®) or Celebrex®. There is some concern, however that these medications can increase the risk of cardiovascular problems in patients who are at risk.

Pfizer is conducting a large scale study at hundreds of sites around the world to determine which of these medications is safest for patients who are at risk of cardiovascular disease. Risk of heart disease is based on (a) coronary artery disease, (b) peripheral vascular disease, (c) diabete [if female, then diabetes requiring insulin] or (d) a combination of age, smoking, high blood pressure, family history of premature cardiovascular disease, and other risk factors. Patients who have osteoarthritis or rheumatoid arthritis that requires treatment with anti-inflammatory medication and meet one or more of the cardiovascular risk criteria may be eligible for this study. Patients enrolling in the study will be randomly assigned to receive one of three widely used arthritis medications (ibuprofen, naproxen, or Celebrex®) over the course of the study.

If you are interested in learning more about any of these studies, you can speak with your pain management providers or contact me directly at TedS@arizonapain.com. Ted Swing has more than nine years of research experience and four years of teaching experience in psychology, has published in top psychology and medical journals, and has presented his research at major conferences. He received his Ph.D. in Social Psychology from Iowa State University and has been the Research Director at Arizona Pain since May 2012.